Safety, Tolerability, and Pharmacokinetic Study of Concomitant Chloroquine and Tafenoquine in Healthy Volunteers

Eligibility

Ages Eligible for Study:

18 Years to 55 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECGs. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the Investigator and GSK medical monitor agree that the abnormality will not introduce additional risk factors and will not interfere with the study procedures.

Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.

A female subject is eligible to participate if she is of non-childbearing potential or of child-bearing potential if has a negative urine pregnancy test at screening and Day -1, and agrees to use agreed upon contraception methods until 56 days after stopping study drug.

Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria:

A positive urine drug/alcohol screen at screening or Day -1.

History or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.

History of illicit drug abuse within 6 months prior to screening.

History of regular alcohol consumption within 6 months of the study

Subjects who are unwilling to comply with the lifestyle guidelines required.

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).

Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication.

History of sensitivity to any of the study medications or their components.

Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.

Pregnant females as determined by positive urine hCG test at screening or prior to dosing.

The subject's systolic blood pressure is outside the range of 90-150mmHg or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects and 45-100bpm for male subjects at screening and Day -1.

Cardiac conduction abnormalities as specified inprotocol

Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871156